Manager, Quality Assurance, Therapeutic Products Program | GenomeWeb

Manager, Quality Assurance, Therapeutic Products Program

Organization
Seattle Cancer Care Alliance
Job Location
Seattle, WA
Salary
Benefits
Job Description

Fred Hutchinson Cancer Research Center (FHCRC), home of three Nobel laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical research to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone-marrow transplantation, the Center's five scientific divisions collaborate to form a unique environment for conducting basic and applied science.

The Hutchinson Center, in collaboration with its clinical and research partners, the University of Washington and Seattle Children's, is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest. Join us and make a difference!

FHCRC recently consolidated its Cellular and Biological materials process development and GMP manufacturing resources into a Therapeutic Products Program encompassing a total of six separate shared resources. This program will coordinate all internal and external customer needs including scheduling, capacity evaluation, pricing, regulatory oversight, pricing and billing.

As part of this new initiative, we are establishing a Quality Assurance department to manage the quality program associated with both GMP facilities and liaise with the Seattle Cancer Care Alliance quality assurance system. The Quality Assurance group is an integral part of the program providing oversight for all manufacturing protocols and managing the FDA relationship. We are seeking a GMP Quality Assurance Manager to provide direct management for our Quality Assurance department.

- Act as manager for the Quality Assurance Shared Resource within the GMP Therapeutic Products program.
- Manage four to five full-time Quality Assurance employees providing support to internal investigator protocols as well as external collaborative partners.
- Establish and ensure appropriate Quality Systems are implemented and maintained, including ongoing data analysis of product and process outputs to ensure early detection and response to quality improvement opportunities and prevention of quality issues
- Ensure compliance with all quality policies and continuous quality improvement initiatives
- Provide expertise and guidance in interpreting governmental regulations, agency guideline and internal policies to ensure site compliance
- Provide coaching and mentorship to the Quality team, ensuring appropriate levels of accountability for quality decisions and clearly communicates cross-functionally within the organization
- Manage all aspects of plant quality systems, including document control, deviations, CAPA, supplier quality, change control, in-process quality assurance, quality control (analytical and microbiology laboratories), finished product review and release
- Hire and manage departmental personnel directly.

- Work with other Quality/Compliance, Operations, Planning, Logistics, Purchasing and Finance managers and personnel to effectively create and support process and quality enhancement initiatives
- Support an aggressive Quality Program, which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies
- Create and maintain an environment of excellence, world-class quality and continuous improvement throughout the entire plant
- Make fact-based, scientifically sound, quality decisions regarding products manufactured at the facility within the requirements of cGMPs and applicable regulatory/industry guidance documents
- Manage approval or rejection of starting materials, packaging materials, bulk and finished products per the appropriate regulations and site policies and procedures
- Execute and maintain a clear quality vision and strategy for the site
- Supply the highest level of internal and external customer service and measure this through the maintenance and communication of site quality metrics
- Lead and/or support investigations

- Author, approve and/review area quality deviations and investigation reports as appropriate
- Ensure on-time completion of all corrective action items
- Lead the application of appropriate quality technology tools to establish and maintain process capability, and support systems for current pharmaceutical manufacturing
- Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment
- Notify management immediately of unsafe conditions or practices, unlawful activities and activities, which present unreasonable health and/or environmental risk
- Complete other duties as assigned with or without accommodation

- Bachelor of Science in Chemistry or Life Science, Masters degree preferred.
- 10 years of experience within the pharmaceutical or biotechnology industry (preferred) or academic setting.
- 5 years of experience in the manufacturing of Cellular Therapeutic products
- 5 years in a managerial role managing a team(s) of quality individuals
- Lean/Kaizen/Six Sigma working knowledge preferred
- Experience in working closely with and establishing cross-functional teams for process improvement efforts
- Experience in strong management and budgetary responsibilities in most recent position
- Experience in developing/documenting procedures
- cGMP training experience
- Project management experience

- Expert knowledge of cGMP requirements
- Prior experience in managing inspections performed by FDA and other regulatory authorities.
- Thorough understanding of quality systems
- Complete understanding and application of principles, concepts, practices and standards for testing performed in all QC laboratories
- Expertise in the manufacture and control of finished pharmaceutical products, analytical analysis techniques and statistical quality control
- Strong working knowledge of FDA requirements and guidance documents
- Ability to use relevant software packages to process and analyze data
- Ability to lead an organization during a period of organizational growth and change
- Ability to establish timelines and accountability for Quality and Cross-Functional Team projects
- Excellent written and verbal communication skills

To apply for this position, please CLICK HERE

Requirements
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